The Johns Hopkins University is deeply committed to the protection of human research subjects. This commitment begins with comprehensive compulsory education and training of our faculty, student, and staff researchers who conduct human subjects research. It continues with the development of a comprehensive program to support our institutional review boards (IRBs) and our investigators involved in human subjects research. The University has a total of eight IRBs which will be expanded to nine in September 2003: five in the School of Medicine, two in the School of Public Health (becoming three in September 2003) and one in the School of Arts and Sciences. These boards oversee approximately 3,500 protocols that directly involve more than 50,000 human participants. During the past year, we have continued an intensive review of our entire human subjects protection program, including the policies, procedures, practices and support systems of our IRBs. Based on the insights that we have gained, and our intent to apply for accreditation, we have formulated the goal of continuing the development of improved electronic work process and data systems needed to support our protection of human subjects. Accordingly, we wish to focus this grant on the following specific aims: 1. To convert the IRB protocol submission and review processes to paperless electronic work process systems that will enhance the timeliness and consistency of the protocol submission and review process, be a source of protocol status communication, assure consistent human subjects protection program compliance with federal regulations and institutional procedures and policies, improve the monitoring of approved studies and assure accurate records for our IRBs. 2. To plan and begin development of an interactive research subject registry that could provide investigators, clinicians, IRBs and compliance staff with information about the subjects, protocols and non-study clinical events experienced by the subjects; thereby improving clinical care, assuring investigator and IRB knowledge of potential adverse events, providing data on what research patient care is funded by the research study and what privacy authorization has been specified by the subject.